Traditionally, fluid products such as biopharmaceuticals, food and beverages have been processed in stainless steel path ways. The steel piping and fluid path ways need to cleaned such as with a hot caustic solution and then rinsed with several volumes of hot water and steam sterilized in between each use.
One problem with such a system is making sure the system is properly cleaned and sterilized in between each use. Another issue is that the system is incapable of being flexible in size or configuration, limiting the user to a set volume and methodology dictated by the configuration.
This has led to the recent adoption of plastic flexible containers and systems based on them. Most simply are plastic assemblies such as bags connected to each other by plastic tubing. One problem with such systems is that the system cannot be used at any high pressures due to the limitations of the plastic itself. A second issue is that it needs to be stabilized or retained to the surface on which it is used.
One approach has been to use a clam shell or two piece manifold having a flow channel configuration or a relatively flat compressible surface between which the tubing of an assembly and/or the entire assembly can be held so that it can be kept in place and provided with some pressure resistance. See WO 2009/017614.
Another option is to use as flat or unconfigured bag and manifolds that contain the desired flow channels in the manifolds. The bag is placed between the manifolds and slightly constrained. The bag portions corresponding to those portions below the flow channels of the bag are then slightly inflated with a gas or liquid such that the bag portions fill the flow channels of the manifolds. The manifolds are then closed around the bag forming the desired flow path within the bag while in the manifolds, See FR 0959435 filed Jan. 23, 2009.
These devices have their limitations in terms of their complexity of operation and manufacture and their potential for leakage at pressure. For example, the use of separate components such as bags and tubes or an unconfigured bag and placing them in a manifold still limits one to the pressures at which the device may be run as the bag and often the tubes pressure resistance is only marginally improved by the use of the shell or manifolds. This is even more accentuated in the system using only a bag and forming the fluid pathways by inflating portions of the bag into the channels formed in the manifold inner surfaces. In this instance, the seal between the layers of the bag limits the amount of pressure that can be used. Additionally, when using individual components such as tubes connected to bags through a plastic port welded to the bag, one has to deal with obtaining and maintaining a good liquid tight seal between all the components. Most often a leak will occur where the tube is secured to the bag. The manifold devices do not stop such leaks from occurring and running the system at higher pressure and exacerbate the leak in some instances.
The present invention provides a different device for forming a disposable pathway that is capable of holding and operating at high pressures and eliminating the leaks that may occur in other assemblies.